Posted to MedZilla on 2/16/2020


Takeda Pharmaceuticals

US-MA, Head of Gene Therapy Analytics and Bioassays SR0044207-MZ


 
 

PURPOSE:

Are you looking for a patient-focused company that enables transformative technologies to address patients needs while inspiring you and support your career? Takeda is a world-class organization where we combine our expertise in disease biology, modality technologies and drug development experience to develop gene therapies in a holistic approach. We are seeking a highly motivated leader with substantial experience in vector design and gene therapy drug development experience to join Takeda to advance our gene therapy research effort. Be empowered and join us as a Head of Analytical & Bioassays in the Global Gene Therapy Research Team.

OBJECTIVES:

As one of the leaders of the Global Gene Therapy (GGT) Research Team, the Head of Analytical & Bioassays will be responsible and accountable for leading a team of assay leads that contributes to discovery research gene therapy (GT) projects in the research pipeline. The incumbent will lead the team to continue to establish collaborations across multiple line functions to progress GT projects in a highly matrixed manner.

ACCOUNTABILITIES:

  • Provide leadership to a team of analytical leads to design, establish and execute analytical assays and experiments. Responsible and accountable for conducting studies and appropriate data interpretations of the results of studies conducted by self and team members.
  • Represent the Analytical & Bioassay team as the GGT LT member. Ensure cross team collaboration within GGT to obtain required resources to enable efficient progression of GT projects.
  • Enable the Analytical Bioassays team members to cross collaborate within the GGT team.
  • Constantly oversees project progression, experimental prioritization and communicate effectively to GGT LT in a timely manner.
  • Ability to balance multiple projects under a demanding timeline while providing guidance to a team of scientists.
  • Provide subject matter expertise and leadership in developing analytical methods for nucleic acid gene delivery vector candidate s characterization for research grade vectors used in preclinical research.
  • Serve in multiple project subteams and lead coordinate multiple projects and analytical and bioassays team members to communicate between Research and Pharm Sci from early development to development candidate transition and beyond.
  • Act as gene therapy vector analytical expert from research and ensure accurate technical transfer to Pharm Sci.
  • Lead the Analytical and Bioassay team to contribute to CMC subteam by overseeing development and execution of experiments involved in vector characterization
  • Coordinate international shipment of viral vectors and reagents among internal sites and external CROs/CMOs.
  • Accountable for the development of organizational culture and capabilities.
  • Ability to balance multiple projects under a demanding timeline while providing guidance to a team of scientists.
  • Responsible for management of resourcing and budget planning for his/her area of focus.
  • Demonstrate good organizational and communication skills.
  • Expected to be accountable for effectiveness and timelines of completion of project goals.
  • Follow compliance of documentation in electronic lab notebook and author scientific reports that supports internal documentation and regulatory submissions.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

  • Outstanding expertise and depth of knowledge within a scientific area
  • Keeps up with the up-to-date scientific advancement (e.g. competitive landscape, new technology, new research portfolio, and new partnership)

Leadership

  • Scientific leadership role, setting high standards for effectiveness of execution, and rigor of thought
  • Has significant managerial responsibility

Interaction

  • Initiates and leads external interactions and collaborations
  • Frequent contact with internal and external personnel at various management levels

Innovation

  • Determines methods on new assignments; makes strategic recommendations on projects

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • PhD degree in a scientific discipline with 10+ years of experience. Prior managerial experience required.
  • Minimum 5 years of relevant experience in bioanalytical and analytical characterization of nucleic acid (DNA, RNA, oligos, etc) with viral and/or non-viral delivery vehicle use in research and development.
  • Proficiency in mammalian cell culture, hands-on laboratory skills in cell-based assays, protein quantitation such as ELISA, quantitative PCR methods, and other plate-based assays are required.
  • Experience with gene therapies using viral approaches is required.
  • Experience with viral vectors is required and previous management of CROs is a plus.
  • Prior experience in establishing analytical methods and conducting analytical and bioassays suitable for viral vector characterization.
  • Prior experience in the research environment to support CMC subteam for research grade, GLP and GMO materials characterization.
  • Experience with writing assay protocol, documentation and study reports that could contribute to regulatory filing documents.
  • Experience in the development of molecular biology test methods not limited to PCR (qPCR, ddPCR), TCID50, transduction assay, ELISA, SDS Page, Capillary Electrophoresis, AUC, and cell based potency assays with internal and CRO effort.
  • Excellent technical writing and communication skills with structured organizational skills that enables clear and accurate information transfer.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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